![]() ![]() ![]() The discovery, development and application of therapeutic peptides/proteins or chemical drugs are rapidly increasing. The review provides an overview on the development of the system in pharmaceutical industry. ![]() Finally, we focus on the current FDA guidance on the DDS. In this review, we present some recent achievement of the PLGA/PLA microspheres/nanoparticles, and discuss some promising manufacturing methods. Furthermore, the relevant FDA guidance on the DDS is still incomplete, especially for abbreviated new drug application. Some of the methods are easy to scale up, and have been available on the market to achieve pilot scale or even industrial production scale. Recently, many new and modified methods have been developed to overcome the above problems. There have been 15 products available on the US market, but the system still has many problems during development and manufacturing, such as wide size distribution, drug stability issues, and so on. Because of good biocompatibility and biodegradability, they can be used in various areas, such as long-term release system, vaccine adjuvant, tissue engineering, etc. Poly(D,L-lactic-co-glycolic acid) (PLGA)/poly(lactic acid) (PLA) microspheres/nanoparticles are one of the most successful drug delivery systems (DDS) in lab and clinic.
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